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New surgical procedures can expose patients to harm and should be carefully evaluated before widespread use. The InSpace balloon (Stryker, USA) is an innovative surgical device used to treat people with rotator cuff tears that cannot be repaired. We aimed to determine the effectiveness of the InSpace balloon for people with irreparable rotator cuff tears.We conducted a double-blind, group-sequential, adaptive randomised controlled trial in 24 hospitals in the UK, comparing arthroscopic debridement of the subacromial space with biceps tenotomy (debridement only group) with the same procedure but including insertion of the InSpace balloon (debridement with device group). Participants had an irreparable rotator cuff tear, which had not resolved with conservative treatment, and they had symptoms warranting surgery. Eligibility was confirmed intraoperatively before randomly assigning (1:1) participants to a treatment group using a remote computer system. Participants and assessors were masked to group assignment. Masking was achieved by using identical incisions for both procedures, blinding the operation note, and a consistent rehabilitation programme was offered regardless of group allocation. The primary outcome was the Oxford Shoulder Score at 12 months. Pre-trial simulations using data from early and late timepoints informed stopping boundaries for two interim analyses. The primary analysis was on a modified intention-to-treat basis, adjusted for the planned interim analysis. The trial was registered with ISRCTN, ISRCTN17825590.Between June 1, 2018, and July 30, 2020, we assessed 385 people for eligibility, of which 317 were eligible. 249 (79%) people consented for inclusion in the study. 117 participants were randomly allocated to a treatment group, 61 participants to the debridement only group and 56 to the debridement with device group. A predefined stopping boundary was met at the first interim analysis and recruitment stopped with 117 participants randomised. 43% of participants were female, 57% were male. We obtained primary outcome data for 114 (97%) participants. The mean Oxford Shoulder Score at 12 months was 34·3 (SD 11·1) in the debridement only group and 30·3 (10·9) in the debridement with device group (mean difference adjusted for adaptive design -4·2 [95% CI -8·2 to -0·26];p=0·037) favouring control. There was no difference in adverse events between the two groups.In an efficient, adaptive trial design, our results favoured the debridement only group. We do not recommend the InSpace balloon for the treatment of irreparable rotator cuff tears.Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health and Care Research partnership.

Aim To explore reasons for the poor uptake of accredited diabetes self-management education (DSME) in adults with Type 1 diabetes. Methods The study was set in an urban population in South London, UK. A cross sectional survey gathered demographic, diabetes service-use data, psychological scores and reasons for non-attendance at locally-available DSME. In addition, 56 healthcare professionals were surveyed. Results Responses to surveys were returned by 496 adults with Type 1 diabetes (33% response rate), of whom 263 had attended DSME (53%). Multivariable analysis adjusted for significant variables identified four key variables influencing attendance. Non-attendance was associated with men (OR 0.55 CI 0.37-0.84, p = 0.005), lower educational attainment (OR 0.45 CI 0.28-0.73, p = 0.001), higher glycated haemoglobin (OR 1.74 CI 1.03-2.94, p = 0.04) and healthcare professional encouragement to attend (OR 1.7 CI 1.28-2.3, p = 0.001). The most frequently reported barriers to attendance were work (37%) and time (14%) commitments. Only 49% of healthcare professionals (HCPs) correctly identified the most likely barriers. Those HCPs who had observed courses believed more in their efficacy, with higher uptake within their clinic population. Conclusions Social determinants of health, particularly educational attainment and gender, increase health inequalities by influencing decisions to attend evidence-based education courses. Healthcare professional communication is paramount to encourage attendance, and observation of a course may facilitate this.

BackgroundMore than a quarter of the UK population are affected by depression during their lifetime. For major trauma patients, postinjury depression can result in poorer long-term outcomes, but there is limited evidence regarding outcomes for patients with pre-existing depression. This study investigated the relationship between a diagnosis of depression prior to hospital admission and clinical outcomes after major trauma.MethodsTrauma patients at a UK major trauma center were identified during a 6.5-year period using the Trauma Audit and Research Network database. Patients with Injury Severity Score >15 who did not die in the emergency department (ED) were included. Logistic regression models were used to compare in-hospital mortality (excluding ED), requirement for surgery, and length of stay (LOS) between those with depression and those without.ResultsThere were 4602 patients included in the study and 6.45% had a diagnosis of depression. Depression was associated with a significant reduction in mortality (OR 0.54, 95% CI 0.30 to 0.91; p=0.026). However, patients with depression were more likely to have longer LOS (OR 124, 95% CI 8.5 to 1831; pDiscussionA pre-existing diagnosis of depression has complex association with clinical outcomes after major trauma, with reduced mortality but longer LOS and higher likelihood of surgical intervention. Further prospective investigations are warranted to inform optimal management strategies for major trauma patients with pre-existing depression.Level of evidenceIII.

© 2019 - IOS Press and the authors. All rights reserved. BACKGROUND: Disorders associated with the rotator cuff are regarded as the most common shoulder pain presentation. The range of diagnostic terms used to explain this problem reflect uncertainty in relation to causative mechanisms, diagnosis, prognosis, and the most effective treatments. The aim of this consensus exercise was to facilitate a shared understanding as a means of reducing mixed messages, informing clinical practice and providing a foundation for future research. METHODS: Nine physiotherapists with clinical and academic expertise in shoulder pain participated in an online and face-to-face consensus exercise. RESULTS: This consensus exercise suggests specific factors in the history and physical examination that might raise the index of suspicion of Rotator Cuff Related Shoulder Pain. The suggestions for non-surgical management include a minimal number of exercises prescribed to challenge the functional deficit of the patient over a minimum 12-week period. Apart from aiding exclusion of red flag pathology, imaging is not regarded as useful unless the patient does not respond as expected. Steroid injections wouldn't be considered a first-line intervention unless pain was severe and preventing engagement with exercise. CONCLUSION: This consensus exercise provides a benchmark for clinical reflection while highlighting areas of uncertainty that still exist and require further research.

BESS Surgical Procedure Guidelines (SPGs). Optimising Surgical Outcomes for Shoulder and Elbow patients. The British Elbow and Shoulder Society (BESS) SPGs are a series of evidence and consensus Best Practice Recommendations developed by BESS surgeons and physiotherapists to help drive quality improvement and achieve the best possible surgical outcomes for UK patients. This SPG on primary and revision elbow replacement surgery is supported and endorsed by both the British Orthopaedic Association (BOA) and the Getting It Right First Time (GIRFT) Programme.

OBJECTIVE Annual diabetic eye screening has been implemented in England since 2008. This study aimed to estimate changes in the detection of retinopathy in the first 4 years of the program. RESEARCH DESIGN AND METHODS Participants included 32,340 patients with type 2 diabetes resident in three London boroughs with one or more screening records between 2008 and 2011. Data for 87,570 digital images from 2008 to 2011 were analyzed. Frequency of sight-threatening diabetic retinopathy (STDR) was estimated by year of screen for first screens and for subsequent screens according to retinopathy status at first screen. RESULTS Among 16,621 first-ever screens, the frequency of STDR was 7.1% in 2008, declining to 6.4% in 2011 (P = 0.087). The proportion with a duration of diabetes of CONCLUSIONS After the inception of population-based diabetic eye screening, patients at lower risk of STDR contribute an increasing proportion to the eligible population, and the proportion detected with STDR at second or subsequent screening rounds declines rapidly.

This study evaluated whether repeated non-attendance for diabetic eye screening is associated with the risk of sight-threatening diabetic retinopathy (STDR). This was a cohort study of 6,556 residents with diabetes who were invited for screening between 2008 and 2011 in a population-based eye screening programme in inner London and who attended for their first-ever screen in 2008. The proportion of participants with STDR was evaluated in relation to the number of years in which screening was missed. The proportion of participants who did not attend screening decreased between 2009 and 2011 (annual reduction 1.6% [95% CI 0.9%, 2.3%]). The adjusted relative odds of STDR for 210 participants who did not attend two consecutive years of screening were 3.76 (95% CI 2.14, 6.61; p

Background Population-based diabetes eye screening aims to reduce the occurrence of visual loss from diabetic eye disease. This study evaluated whether repeated non-attendance for diabetes eye screening is associated with risk of sight-threatening diabetic retinopathy (STDR). Methods A population-based cohort study was conducted using diabetes eye screening appointments and results bare presented for N = 35,253 patients resident in three South London boroughs invited for screening between 2008 and 2011. Analysis examined associations between the number of years in which screening was missed and risk of sight-threatening diabetic retinopathy. We also describe uptake and socio-demographic and clinical associations with non-attendance. Results There were 16,985 participants who were invited for screening in all four years, from 2008 to 2011, including 10,208 (60%) who were screened in every year, 6,564 (39%) who did not attend screening for up to three years, and 213 (1%) who did not attend screening in any year. Compared with participants who were screened annually, the adjusted relative odds of STDR were 2.28 ([95% CI 1.86, 2.78], p Conclusion Patients who do not attend diabetes eye screening are at increased risk of developing sight threatening diabetic retinopathy. This risk is greater after two years of non-attendance or when background retinopathy has already been diagnosed. Quality assurance in the screening programme should focus on repeat non-attenders who already have some evidence of retinopathy.